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ATTENTION HOSPITAL PHARMACISTS AND PHYSICIANS: IMPORTANT RECALL INFORMATION

Sandoz Pharmaceuticals is recalling multiple lots of fomepizole injection apparently due to FDA concerns at one of the manufacturing facilities. The affected lots are:

Description

 Item number

 Manufacturer

 NDC/UPC

 Lot #

 Expiration Date

 Manufacturer

 Initial ship date

 Fomepizole 1.5 g – 1.5 ml vl  4 x 1.5 ml

 10052374

 823955

 0781318284

VFMA 032-  4/30/2015

VFMA 033- 7/31/2016

VFMA 034 -10/30/2017

 

 06/01/2013

 Fomepizole 1.5 g – 1.5 ml vl  1.5 ml

 10057940

 932475

 0781318273

VFMA 029 – 3/31/2015

VFMA 030 – 4/30/2015

VFMA 031 – 4/30/2015

VFMA 032 – 4/30/2015

VFMA 033 – 7/31/2016

VFMA 034 –10/31/2017

 06/01/2013

 

The Carolinas Poison Center recommends the following:

If you do not have these lots, there is no reason for concern.

If you have these lots, please contact your distributor regarding returns.

          Check your facility stock of dehydrated alcohol (98% ethanol) if you have it.

          Check your facility stock of oral ethanol beverages if you or your dietary department carries it.


If you have a patient present to your facility that may have ingested either ethylene glycol or methanol, please call the Carolinas Poison Center for assistance.

We can assist in determining the following:

  • What is the likelihood the patient will need antidotal therapy?
  • Do you or facilities near you have available antidote?
  • Does the patient need to be transferred for antidotal therapy?
  • If the patient needs antidotal therapy and fomepizole is not available, what is the best way to manage the patient?
  • Is there an alternative dosing regimen that may be suitable for the patient?

Carolinas Poison Center is staffed 24/7 by Certified Specialists in Information (nurses, pharmacists). A toxicologist is always available for consultation.

1-800-222-1222

 

 



Carolinas Poison Center    P.O. Box 32861    Charlotte  NC    28232-2861    1-800-222-1222  •  © 2017